Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

Iron Deficiency Clinical Trial

— Prefer  

Official title:

A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110356
• Other study ID #: IDNA 2009-01
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2010
• Last updated: November 13, 2012
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to study specific procedures.

• Premenopausal, regularly menstruating women.

• Age =18 years.

• Body weight between 50 and 90 kg.

• Haemoglobin =115 g/L.

• Iron deficiency at screening defined as follows:

• S-ferritin level <50 ng/mL, AND, TfS <20%, OR,

• S-ferritin level <15 ng/mL.

• Serum C-reactive protein:

• <5 mg/L if not on oral contraception, OR,

• <20 mg/L if use of oral contraception.

• Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23).

• Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening.

• Normal levels of vitamin B12 and folic acid at screening.

• Adequate contraception during the study period and for 1 month following study completion.

• Availability and willingness to complete all study visits and procedures per protocol.

Exclusion Criteria:

• Haemoglobin level <115 g/L.

• Haemoglobinopathy.

• Haemochromatose.

• Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores =2; one of which corresponds to question number 1 or 2).

• Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV).

• Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.

• Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease).

• Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea.

• Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness).

• Important recent weight loss (>10% within the past month).

• Body weight <50 kg or >90 kg.

• Thyroid dysfunction, thyroid stimulating hormone >4 µU/mL.

• Intake of iron preparations 4 weeks prior to screening.

• Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35).

• Known hypersensitivity to FCM or to any other iron preparation.

• Pregnancy (positive hCG test at screening) or breast feeding.

• Participation in any other interventional trial within 4 weeks prior to screening.

• Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion.

• Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.

• Subject previously has entered this study.

• Subject will not be available for follow-up assessments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Drug:
• Ferinject
Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.

Other:
• Saline
Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.

Locations

Country	Name	City	State
Austria	Universitätsklinik für Frauenheilkunde	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	SGS

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age.		Day 56	No
Secondary	To compare efficacy of a single IV application of FCM with that of placebo on change of iron status on Day 56 (i.e., proportion of subjects with haemoglobin (Hb) =12 g/dL; serum-ferritin (s-ferritin) =50 ng/mL; transferrin saturation (TfS) >20%).		Day 56	No
Secondary	To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms.		Day 56	No